Argon Medical Productions & Vertrieb Gesellschaft MBH & CO FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection OAI · Jul 31, 2024
  • Last warning letter 2024
Inspections 1 1 OAI
Recalls 0 0 Class I
Warning letters 2 Latest Nov 22, 2024
510(k) clearances 0 None on file

Argon Medical Productions & Vertrieb Gesellschaft MBH & CO has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 2 warning letters to Argon Medical Productions & Vertrieb Gesellschaft MBH & CO, the most recent on Nov 22, 2024.

What these totals cover: FDA records filed under the name "Argon Medical Productions & Vertrieb Gesellschaft MBH & CO" and its spelling variant "Argon Medical Productions And Vertrieb Gesellschaft Mbh And".

Latest inspection
Jul 31, 2024 · OAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Reviewing Argon Medical Productions & Vertrieb Gesellschaft MBH & CO as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Argon Medical Productions & Vertrieb Gesellschaft MBH & CO yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Argon Medical Productions & Vertrieb Gesellschaft MBH & CO FDA Warning Letters

2 warning letters from Oct 22, 2024 to Nov 22, 2024.

IssuedSubjectIssuing officeClose-out letter
Nov 22, 2024 · Letter on fda.gov CGMP/QSR/Medical Devices/Adulterated/MisbrandedCenter for Devices and Radiological Health
Oct 22, 2024 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

1 inspection on Jul 31, 2024.

DateSiteProductClassificationFEI
Jul 31, 2024Bingen Am Rhein, GermanyDevicesOfficial Action Indicated (OAI)3011575197
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Argon Medical Productions & Vertrieb Gesellschaft MBH & CO: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 22, 2024.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3011575197Bingen Am Rhein, Germany1Jul 31, 2024

Argon Medical Productions & Vertrieb Gesellschaft MBH & CO and the FDA: common questions

Has Argon Medical Productions & Vertrieb Gesellschaft MBH & CO received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Argon Medical Productions & Vertrieb Gesellschaft MBH & CO. The most recent is dated Nov 22, 2024, with the subject "CGMP/QSR/Medical Devices/Adulterated/Misbranded".

Has Argon Medical Productions & Vertrieb Gesellschaft MBH & CO received an FDA Form 483?

FDA has not published a Form 483 for "Argon Medical Productions & Vertrieb Gesellschaft MBH & CO" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Argon Medical Productions & Vertrieb Gesellschaft MBH & CO?

The most recent FDA inspection on file ended Jul 31, 2024 at Bingen Am Rhein, Germany and was classified OAI. FDA has 1 inspection of Argon Medical Productions & Vertrieb Gesellschaft MBH & CO on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Argon Medical Productions & Vertrieb Gesellschaft MBH & CO in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.

Get a free API key

Prefer a PDF? Request a free supplier snapshot.

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.